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Subpart B—Clinical Chemistry Test Systems
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LNW
Paper, Obstetric Ph
1
Product Code
K
03
2161
PHEM-ALERT
1
Cleared 510(K)
K
01
2230
PHEM-ALERT
1
Cleared 510(K)
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96
0648
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1
Cleared 510(K)
K
85
0858
OB-PH - PH TEST PAPER
1
Cleared 510(K)
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Last synced on 14 February 2025 at 11:05 pm
OB
/
subpart-b—clinical-chemistry-test-systems
/
LNW
/
K012230
View Source
PHEM-ALERT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012230
510(k) Type
Traditional
Applicant
FEMTEK,LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/2001
Days to Decision
85 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
LNW
Paper, Obstetric Ph
K
03
2161
PHEM-ALERT
K
01
2230
PHEM-ALERT
K
96
0648
PHEM-CHEK
K
85
0858
OB-PH - PH TEST PAPER
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-b—clinical-chemistry-test-systems
/
LNW
/
K012230
View Source
PHEM-ALERT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012230
510(k) Type
Traditional
Applicant
FEMTEK,LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/2001
Days to Decision
85 days
Submission Type
Summary